| Yesterday | ||||
| Over a month ago | ||||
electroCore provided an… electroCore provided an update on ongoing nVNS COVID-19 initiatives. The company announced that an investigator-initiated, randomized, controlled clinical trial of nVNS therapy has commenced enrolling COVID-19 patients in Spain. The trial, "Prospective, Randomized, Controlled Study to Evaluate the Effect of Non-Invasive Electrical Vagus Nerve Stimulation on Respiratory Symptoms due to COVID-19," is designed to assess the ability of nVNS to decrease the number of hospitalized COVID-19 patients requiring use of a ventilator. In the treatment group, nVNS will be provided in addition to the current standard of care. nVNS will be used prophylactically, three times a day, as well as acutely when needed by patients, with the goal of improving breathing and decreasing the need for mechanical ventilation. The control group will consist of patients matched to the stimulation group in terms of severity and will be treated with standard of care alone. The trial is being led by Dr. Carlos Tornero, M.D., Head of the Anesthesiology-Resuscitation Department, Hospital Clinico Universitario de Valencia. Multiple US institutions have expressed interest in conducting additional controlled clinical studies of nVNS' potential utility in treating COVID-19 patients. A second investigator-initiated randomized, controlled trial protocol was recently approved by the Institutional Review Board at one U.S. institution and should commence soon. Additional U.S. investigator-initiated trials are under consideration. The company also announced that a paper, entitled, "Use of Non-Invasive Vagus Nerve Stimulation to Treat Respiratory Symptoms Associated with COVID-19: A Theoretical Hypothesis and Early Clinical Experience," has gone through peer review and been accepted for publication by the highly-regarded journal Neuromodulation: Technology at the Neural Interface. The paper will be made available via open access when published online in the near future. | ||||
Premium II is a… Premium II is a company-funded study designed to support electroCore's proposed expansion of the gammaCore label into migraine prevention. As previously reported, the company has suspended enrollment in this study to further conserve cash. The company has initiated necessary steps to close the Premium II clinical trial and assess the data that has been collected from the trial to this point. As a result, there are currently no company-funded studies that are ongoing. It should be noted, however, that a number of investigator-initiated clinical trials of gammaCore in new indications are progressing, including in respiratory distress secondary to COVID-19. These trials are largely funded by third party grants, and the company intends to report results from these studies as they become available. | ||||
During the first quarter… During the first quarter of 2020, electroCore shipped 1,008 paid months of therapy outside of the U.S., up from 961 paid months of therapy in the fourth quarter of 2019 and 828 in the third quarter of 2019. On April 8, 2020, the company announced that the U.K.'s National Health Service exercised its option to extend the Innovation and Technology Payment Program through September 2020. As such, gammaCore will continue to be reimbursed for those patients in England who suffer from cluster headache and respond to therapy. | ||||
Continuing a positive… Continuing a positive trend observed in prior quarters, 64 Veterans Administration and Department of Defense military treatment facilities purchased gammaCore products during the first quarter of 2020, as compared to 54 during the fourth quarter of 2019, 48 during the third quarter of 2019 and 35 during the second quarter of 2019. Also, during the first quarter of 2020, the company shipped 1,084 paid months of therapy to VA and DoD facilities, up from 829 during the fourth quarter of 2019 of 2019, 553 during the third quarter and 233 during the second quarter of 2019. FSS encompasses over 10 million covered lives, some 400,000 of whom saw VA healthcare providers for headache in 2018. The Company's U.S. sales function continues to focus on this channel, but its ability to visit hospitals and doctors during the pandemic has been limited. The VA system has an advanced telehealth capability and gammaCore therapy can be prescribed in a telehealth consult and delivered directly to the patient's home, a potential competitive advantage while the hospital system is locked down. That said, it is difficult to forecast the trajectory of the business during this period. | ||||
On April 1, 2020, the… On April 1, 2020, the company submitted an EUA application to the FDA, to facilitate the study and clinical use of its gammaCore therapy for respiratory symptoms associated with COVID-19. The FDA's decision on the company's EUA is pending. | |
As previously reported,… As previously reported, management has suspended full-year revenue guidance until it can better understand the trajectory of the company's business through the COVID-19 pandemic. | |
During the first quarter,… During the first quarter, electroCore used approximately $8.4 million to fund its operations, as compared to $9.4 million in the fourth quarter of 2019. The first quarter of 2020 included use of cash of approximately $1.7 million for previously committed purchases of inventory. Remaining outlays for these inventory commitments are not material. The company expects its average quarterly cash burn to be significantly lower for the balance of 2020. The company ended the first quarter of 2020 with approximately $15.6 million of cash, cash equivalents and marketable securities. Subsequent to the end of the quarter, electroCore raised gross proceeds of approximately $3.1 million through a partial draw down from its recently announced $25 million stock purchase agreement with Lincoln Park Capital. "As we and the rest of the world grapple with the humanitarian crisis and economic uncertainties brought on by the ongoing COVID-19 pandemic, we continue to advance toward our goal of making our gammaCore Sapphire non-invasive vagus nerve stimulation technology available to the broadest possible patient population within our approved adult headache indications," said Daniel Goldberger, CEO. "We have taken significant steps, both operationally and financially, to sharpen our focus on currently available revenue channels, while in parallel creating a streamlined and nimble organizational structure capable of responding quickly to changes in our addressable markets. I am confident that the actions that we have taken to this point will allow us to navigate through the current crisis in the near-term and achieve long-term sustainable growth when a normalized business environment prevails." | |
electroCore announced… electroCore announced that England's National Health Service, NHS, has exercised its option to extend the Innovation and Technology Payment, ITP, Program for the use of gammaCore in the treatment of cluster headache in adults. The extension will run through September 2020 and via this program, which started in April 2019, gammaCore will continue to be reimbursed for those patients in England who suffer from cluster headache and respond to our therapy. "We are pleased to have NHS England maintain their ITP program to fund and support bringing our gammaCore therapy to patients suffering from cluster headache. gammaCore remains the only device approved by the National Institute for Health and Care Excellence, NICE, for use in patients with drug resistant cluster headaches," said Iain Strickland, VP of European Operations, electroCore, Inc. The ITP Program is designed to support the adoption of innovations and technologies in the NHS market through the removal of significant financial barriers for both commissioners and providers. The program provides funding to these MedTech products and promotes a broader set of activities with Academic Health Science Networks, AHSNs, in order to deliver improvements in the quality and efficacy of patient care. | |
electroCore announced… electroCore announced that the company has submitted an Emergency Use Authorization, or EUA, application to the FDA to facilitate the study and clinical use of its gammaCore Sapphire non-invasive vagus nerve stimulation therapy, or nVNS, for respiratory symptoms associated with COVID-19. The EUA includes data from early clinical and non-clinical work that examined the use of the company's VNS, including non-invasive therapy, in several pilot studies that involved patients with a variety of respiratory disorders. These studies suggest a possible benefit for patients with respiratory distress associated with COVID-19. Additionally, gammaCore's safety and tolerability profile suggest that it would be safe to study or use in patients with COVID-19. Although the company believes that clinical data from the referenced pilot studies may suggest a possible benefit for patients with respiratory distress associated with COVID-19, it should be noted that preclinical and clinical data are often susceptible to varying interpretations and analyses, and that such data may not be adequate for the FDA to issue an EUA. It should also be noted that to date no randomized clinical trials have been performed utilizing gammaCore in patients with COVID-19. |